RealLine SARS-CoV-2 lyo REF VBD5580
Manufactured by BIORON Diagnostics GmbH, Germany - www.bioron.de
Device identification number
1459
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
90 minutes
LOD
25 cpr
Positive control
Positive Control for SARS-Cov-2 is included
Negative control
Negative control is included in validated NA extraction kits
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Throughput
96 samples/run
Notes
https://www.bioron.de/product/rl-sars-cov-2-lyo/
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements